The vaginal wall is formed essentially of two sets of muscles, one set which extends longitudinally and a second set which encircles the vagina. In addition, those muscles specifically termed the pubococcygenus and levator ani are located immediately adjacent the vagina and have a critical influence on its proper functioning. These muscles have the general appearance of a hammock with its two ends connected to the sides of the pelvis.
Three hollow tube like structures, urethra, vagina and rectum, extend downwardly through respective openings in the central portion of the pelvic diaphragm or hammock. Where the muscle tone of the pelvic diaphragm is good, these openings are maintained constricted through a pulling together action of the muslces of the hammock in concert with the individual sphincters. On deterioration of muscle tone, either through poor physical condition of the individual or injury, these openings in the diaphragm tend to become progressively larger.
It has been found that the physical condition of the vaginal wall muscles, and particularly those forming the pelvic diaphragm, is directly related to the coital responsiveness of a female patient as well as the pleasure received in sexual intercourse. That is, whereas a lax vaginal musculature tends to make the individual relatively unresponsive to the sexual experience, good vaginal muscle tone heightens the effect.
In view of the fact that the muscles comprising the vaginal musculature are, for most individuals, only partially under voluntary control, specific exercise of these muscles for achieving and maintaining their proper conditions to ensure health and well being has been difficult. Accordingly prior art apparatuses, such as those disclosed in U.S. Pat. Nos. 2,507,858 and 2,541,520 both to Kegel, in U.S. Pat. No. 3,640,284 to De Langis and in U.S. Pat. No. 3,752,150 to Harris, have been developed for indicating or observing indirectly, progressive degrees of exercising of injured sphincter muscles for the purpose of developing, reconstructing or regenerating such muscles. The principle of biofeedback upon which these apparatuses are based is that such muscles as may be injured, torn or which require development, are or may be (because of their inherent characteristics, or their anatomical position, or their psysiological function, or because of injury or tearing thereof, for example during childbirth) difficult or impossible to observe or be cognizant of their function which have, to a degree been lost by such injury, tearing or underdevelopment so that it is not possible for the individual to exercise the muscles in a manner so that the muscles may be redeveloped or regenerated through use. It frequently is possible in muscles of this character which have been injured, torn or underdeveloped for the individual to use or operate them, but the individual generally has no realization of the fact, or degree of fact, of the use of such muscles so that it is impossible to determine the fact of their utilization or activation. The regeneration or reconstruction in the development of these muscles is to the greatest degree dependent upon ability of the individual to use the muscles, to exercise them and through exercise and use to develop and reconstruct them.
Kegel's apparatus, known as a Perineometer, is the best known apparatus of this kind. Kegel's apparatus, however, has had limited clinical use, primarily because of lack of patient acceptance. Clinical interviews have uncovered patient complaints about the large size of the sensing member of Kegel's apparatus. This is a factor which contributes both to a patient's physical and phychological discomfort. As with any device designed to be inserted vaginally, two patient psychologic objections must be overcome, phallic fear and masturbatory guilt. Ordinarily physician reassurance helps to allay these objections, but flesh color and penislike stem of the Kegel apparatus aggravate these objections. Multiple parts of the Kegel apparatus make disassembly, cleaning and reassembly a complex task for the patient and this also discourages regular patient use. The intra vaginal portion of the Kegel apparatus is composed of unfinished natural latex, with the result that surface friction characteristics are such that generous amounts of lubricant are required for easy insertion. Harris appears to have made strides toward overcoming disadvantages of the Kegel apparatus. But Harris retains the stem and he left much to be desired by way of structural simplicity.